Home NDC 68462-590 FLUOCINOLONE ACETONIDE
Product NDC 68462-590
11-digit product format 684620590
Labeler code 68462
Product ID 68462-590_49e4ce6d-f8e8-48f5-90e5-ad7b43170026
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluocinolone acetonide
Dosage form OIL
Route TOPICAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA210539
Marketing category ANDA
Marketing start 2018-10-30
Substance FLUOCINOLONE ACETONIDE
Active strength .11 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210539-001 FLUOCINONIDE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL / TOPICAL 2018-10-26
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL 2018-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL 2018-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210539-001 FLUOCINONIDE ACETONIDE 0.01% OIL / TOPICAL AT 2018-10-26 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base FLUOCINOLONE ACETONIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOCINOLONE ACETONIDE .11 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0CD5FD6S2M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1191307 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68462-590-89 FLUOCINOLONE ACETONIDE 1 in 1 CARTON OIL 1 3 68462-590-89 FLUOCINOLONE ACETONIDE 118.28 mL in 1 BOTTLE OIL 118.28 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-590 FLUOCINOLONE ACETONIDE OIL [GLENMARK PHARMACEUTICALS INC., USA] 3 Current NDC, Legacy NDC, 2 package rows 20240103_47de7132-c692-4c77-8160-ab0c1f501a7c.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68462-590-89 68462059089 1 BOTTLE in 1 CARTON (68462-590-89) / 118.28 mL in 1 BOTTLE 1 bottle 2018-10-30 0000-00-00 No No Current